Phase 3
Completed N=6,564
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
Source: ClinicalTrials.gov NCT02504216 ↗Enrolled (actual)
6,564
Serious AEs
28.8%
Results posted
Dec 2020
Primary outcomePrimary: Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology — 508; 584 Participants — p==0.0043
◆ Published Evidence
Emerging
19citations · ~6 / year
Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.
Summary
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.
Linked Publications (5)
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Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.
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Rivaroxaban in Peripheral Artery Disease After Revascularization: Worst Events and Net Outcomes in VOYAGER PAD.
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Unplanned Index Limb Revascularization With Rivaroxaban Versus Placebo in Patients With Critical Limb-Threatening Ischemia After Endovascular and Surgical Treatment: Insights From VOYAGER PAD.
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Low-Dose Rivaroxaban Plus Aspirin in Patients With PAD Undergoing Lower Extremity Revascularization With and Without History of Prior Limb Revascularization: Insight From the VOYAGER-PAD Trial.
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Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology |
508; 584 | =0.0043 sig |
| PRIMARY Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding |
62; 44 | =0.0695 |
| SECONDARY Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology |
433; 528 | =0.0004 sig |
| SECONDARY Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization) |
584; 655 | =0.0140 sig |
| SECONDARY Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature |
262; 356 | <0.0001 sig |
| SECONDARY Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology |
614; 679 | =0.0145 sig |
| SECONDARY Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology |
514; 588 | =0.0051 sig |
| SECONDARY Number of Mortality (All-cause) |
321; 297 | =0.8322 |
| SECONDARY Number of Participants With Venous Thromboembolic (VTE) Events |
25; 41 | =0.0235 sig |
| SECONDARY Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding |
140; 100 | =0.0068 sig |
| SECONDARY Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events |
93; 73 | =0.0979 |
Eligibility Criteria
Inclusion Criteria
- Age ≥50
- Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
- Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization
Exclusion Criteria
- Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
- Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
- Prior revascularization on the index leg within 10 days of the qualifying revascularization.
- Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for >6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
- Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.
Data sourced from ClinicalTrials.gov (NCT02504216) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.